Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .

• Sponsor: Menoufia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05784181
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.

Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .

One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection .

Condition or Disease	Intervention/Treatment	Phase
Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate	Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser	N/A

Detailed Description

Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation.

Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications .

One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection , so , we try to analyze the effect of Laser enaculation of the prostate in comparison to Bipolar resection in prostate more than 80 gm .

Aim of the work:

Aim of the work is to compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.

Patients and Methods:

A randomized comparative study will be conducted at Menoufia university hospital , urology department. patients will be selected after informed consent.

Inclusion criteria: similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) of >8 , postvoid residual (PVR) <400 ml.

Exclusion criteria: Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .

Preoperatively, all the patients will undergo thorough process of history taking , clinical examination, and investigations in the form of abdominopelvic and trans rectal ultrasonography , PSA ,urine analysis, urine culture if needed and routine pre-operative lab investigations as (CBC , PT, LFTs, serum creatinine and RBS).

The treatment modality chosen for an individual will be randomized . All patients with positive urine culture will be treated by proper antibiotics before the procedures.

Peri-operatively , all patients will receive a single shot of pre-operative antibiotic.

For the first group patients transurethral resection of prostate For the second group patients Laser enaculation by holmium: YAG laser Postoperatively, patients will undergo IPSS score , flowmetry post operative after 3months .

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: patients prostatic volume more than 80 gm turp by bipolar resection pt with 80gm prostate size underwent bipolar resection	Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser; Laser enaculation by holmium: YAG laser
Other: patients prostatic volume more than 80 gm turp by Laser enaculation by holmium: YAG laser pt with 80gm prostate size underwent Laser enaculation by holmium: YAG laser	Device: bipolar transurethral resection and Laser enaculation by holmium: YAG laser; Laser enaculation by holmium: YAG laser

Outcome Measures

Primary Outcome Measures

1. compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram. [1 year]

   compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) <15 ml/s, International Prostate Symptom Score (IPSS) of >8 , postvoid residual (PVR) <400 ml

Exclusion Criteria:

• Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Shibīn Al Kawm	Menoufia -	Egypt	12345

Sponsors and Collaborators

• Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hossam Kandeel, Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine., Menoufia University
• ClinicalTrials.gov Identifier: NCT05784181
• Other Study ID Numbers: 2-2022
• First Posted: Mar 24, 2023
• Last Update Posted: Mar 24, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Mar 24, 2023